Nodari 2011 AF.
| Methods | RCT, parallel, (n3 DHA + EPA vs MUFA), 12 months Summary risk of bias: moderate or high |
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| Participants | Adults with persistent AF with ≥ 1 relapse after cardioversion N: 102 intervention, 103 control (analysed, intervention: 94 control: 94) Level of risk for CVD: high Male: 70% intervention, 63% control Mean age (SD): 70 (6) intervention, 69 (9) control Age range: not reported (18‐80 inclusion criteria) Smokers: 10% intervention, 9.1% control Hypertension: 47% intervention, 40% control Medications taken by ≥ 50% of those in the control group: beta‐blockers, ACE inhibitors, anticoagulant therapy, amiodarone Medications taken by 20%‐49% of those in the control group: diuretics, antiplatelet, statins Medications taken by some, but < 20% of the control group: Ca channel blockers Location: Italy Ethnicity: not reported |
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| Interventions | Type: supplement (Omacor) Comparison: EPA and DH+A vs MUFA Intervention: 2 x1 g/d Omacor (total 1.7 g/d EPA + DHA at a ratio of 0.9‐1.5) Control: 2 x1 g/d olive oil (gelatin capsules identical in appearance to Omacor) Dose aim: increase 1.7 g/d EPA + DHA, 0.8% E n‐3, 0.8% E PUFA Baseline PUFA not reported Compliance by biomarkers: unclear, no biomarkers, no TC reported. Compliance by dietary intake: not reported
Compliance, other measures: none reported Inclusion basis: intended dose was an increase 1.7 g/d EPA + DHA without differences in other PUFAs, so assumed dose 0.8% E PUFA, > 10% increase in total PUFA from assumed baseline of 6% E. No biomarker, TC or dietary intake data to support this. PUFA dose: 0.8% E Duration of intervention: 12 months |
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| Outcomes | Main trial outcome: probability of maintenance of sinus rhythm Dropouts: 6 intervention, 5 control Available outcomes: adverse events, AF recurrence (nil death) Response to contact: no (contact established with trial author but no data received in this trial) |
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| Notes | Trial funding: ‘Centro per lo Studio ed il Trattamento dello Scompenso Cardiaco’ of the University of Brescia, Brescia, Italy. The work of Dr Campia was supported by National Institutes of Health grant K12 HL083790‐01a1 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random assignment followed a computer‐generated randomisation list obtained using blocks of size 4 |
| Allocation concealment (selection bias) | Low risk | The randomisation schedule was kept in the research pharmacy area and was available only to unblinded pharmacy personnel until after the database was locked. At that time, the unblinded patient treatment information was made available to the investigators |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Placebo gelatin capsules identical in appearance to Omacor. However no information provided as to their smell and taste. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomised were accounted for. ITT for main outcomes |
| Selective reporting (reporting bias) | Unclear risk | NCT01198275. Registered retrospectively in September 2010, trial started January 2006, completed May 2008, main publication 2011 |
| Attention bias | Low risk | No difference between groups |
| Compliance | Unclear risk | No biomarkers, no TC reported |
| Other bias | Low risk | None noted |